FDA Upgrades J&J MedTech CEREPAK Recall to Class I After Fatal Incident

The FDA has upgraded the recall of J&J MedTech's CEREPAK embolic protection system to Class I, the most serious level, after a patient death was linked to the device during carotid artery stenting. Investigation revealed the filter failed to fully expand, allowing plaque to escape and cause a fatal intracerebral hemorrhage. The Class I classification requires immediate facility notification, device removal from clinical use, and a thorough root-cause analysis by the manufacturer.